title: Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberté stents in de novo native coronary artery lesions.
abstract: BACKGROUND
  The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS).
  
  
  RESULTS
  The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm(3)/mm versus 0.36±0.63 mm(3)/mm, respectively, P=0.003).
  
  
  CONCLUSIONS
  The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.
authors.affiliation: Center for Cardiovascular Technology, Stanford University, Stanford, CA 94305-5637, USA.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Otake
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Honda
authors.forename: Brian K
authors.initials: BK
authors.lastname: Courtney
authors.forename: Takao
authors.initials: T
authors.lastname: Shimohama
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Waseda
authors.forename: Nathalie
authors.initials: N
authors.lastname: Macours
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Christian
authors.initials: C
authors.lastname: Spaulding
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage; D018084:Ultrasonography, Interventional
chemical_list: D017239:Paclitaxel; D020123:Sirolimus